Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336148
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-03-22
Brief Title:
A Phase 1a1b Study of ACTM-838 in Patients With Advanced Solid Tumors
Sponsor:
Actym Therapeutics Inc
Organization:
Actym Therapeutics Inc
Study Overview
Official Title:
A Phase 1a1b Open-label Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a first in human FIH 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion
Detailed Description:
This study has 2 parts Part 1a will evaluate the safety and tolerability and activity of escalating doses of ACTM-838 to estimate the maximum tolerated dose MTD andor the optimum biological dose OBD for ACTM-838 as a monotherapy and determine the dose recommended for Part 1b
Part 1b will further evaluate ACTM-838 in patients with advanced specific tumor types defined pathologically clinically andor molecularly based on data emerging from the Phase 1a and the pre-clinical program The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment
Part 1b will further evaluate ACTM-838 in patients with advanced specific tumor types defined pathologically clinically andor molecularly based on data emerging from the Phase 1a and the pre-clinical program The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None